July 1, 2025—PathAI has received 510(k) clearance from the U.S. Food and Drug Administration for its AISight Dx digital pathology image-management system for use in primary diagnosis in clinical settings. The FDA decision also included a predetermined change control plan, enabling PathAI to validate and implement specified major changes such as additional displays, scanners, file formats, and browsers into AISight Dx without requiring additional 510(k) submissions.
AISight Dx is cleared for primary diagnosis in the U.S. with the Hamamatsu NanoZoomer S360MD and Leica Aperio GT 450 DX slide scanners and is CE‑IVD marked for primary diagnosis in the EEA, U.K., and Switzerland.